Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

January 19, 2024 updated by: Stanford University

Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial

A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 years old
  • Viable, Singleton pregnancy
  • Voluntarily seeking abortion between 19 and 24wks gestation
  • Able to give informed consent and comply with study protocol
  • Fluent in English or Spanish

Exclusion Criteria:

  • Allergy to misoprostol or mifepristone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Two sets of dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Other: Hygroscopic cervical dilators
Dilapan-S osmostic cervical dilators inserted through the internal os
Other Names:
  • Dilapan-S
Drug: Misoprostol
400mcg buccal misoprostol 90 minutes pre-op
Drug: Intra-amniotic digoxin
1mg digoxin administered intra-amniotically ~24 hours pre-op
Experimental: Mifepristone plus one set of dilators
One set of dilators plus mifepristone
Other: Hygroscopic cervical dilators
Dilapan-S osmostic cervical dilators inserted through the internal os
Other Names:
  • Dilapan-S
Drug: Misoprostol
400mcg buccal misoprostol 90 minutes pre-op
Drug: Intra-amniotic digoxin
1mg digoxin administered intra-amniotically ~24 hours pre-op
Drug: Mifepristone
200mg Mifepristone orally
Other Names:
  • Danco, Mifeprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Time
Time Frame: Intraoperative Time
Measured as time from speculum insertion to removal
Intraoperative Time
Total Procedure Time
Time Frame: Measured at clinic visits and on OR day, over a 3 day period
Measured at clinic visits and on OR day, over a 3 day period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Cervical Dilation
Time Frame: Measured intra-operatively
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Measured intra-operatively
Adverse Events (EBL)
Time Frame: Intraoperatively
One adverse event: Estimated Blood Loss
Intraoperatively
Ease of Procedure by Blinded Surgeon
Time Frame: Measured Immediately after procedure
Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.
Measured Immediately after procedure
Pain Perceived by Patient
Time Frame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.
Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
Overall Patient Experience
Time Frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.
Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
Adverse Events
Time Frame: Intraoperatively and 2 weeks post operatively
uterine perforation, uterine injury, etc.
Intraoperatively and 2 weeks post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Santa Clara Valley Medical Center

Investigators

  • Principal Investigator: Kate A Shaw, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimated)

June 11, 2012

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-05302012-10088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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